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The Aurora Spine ZIP™ MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), lumbar spinal stenosis, spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone use.

The Aurora Spine ZIP™ MIS Interspinous Fusion System is a bilateral locking plate system which attaches to the posterior noncervical spine at the spinous processes. The implants have superior and inferior surfaces and a central chamber for receiving bone graft. The devices are available in a variety of cylinders to accommodate variations in pathology and patient anatomy. The Aurora Spine ZIPTM MIS Interspinous Fusion System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic. lumbar and/or sacral spine.

The provided text describes a 510(k) premarket notification for the Aurora Spine ZIP™ MIS Interspinous Fusion System. This document is a regulatory submission for a medical device and does not contain information about clinical performance testing or studies evaluating the device's adherence to specific acceptance criteria for AI/ML performance.

Specifically, the "Clinical Performance Testing Summary" section states: "A literature review of was performed to support the expanded indications." This implies that no new clinical study was conducted for this specific 510(k) submission to assess performance against acceptance criteria. The submission focuses on demonstrating substantial equivalence to previously cleared devices based on design, materials, and a literature review for an expanded indication (lumbar spinal stenosis).

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment, as this data is not present in the provided document.

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